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FDA APPROVES INJECTABLE CONTRACEPTIVE DRUG DEPO PROVERA

 FDA APPROVES INJECTABLE CONTRACEPTIVE DRUG DEPO PROVERA
 WASHINGTON, Oct. 29 /PRNewswire/ -- The Food and Drug Administration today announced the approval of Depo Provera, an injectable contraceptive drug.
 The drug, which contains a synthetic hormone similar to the natural hormone progesterone, protects women from pregnancy for three months per injection. The hormone is injected into the muscle of the arm or buttock where it is released into the bloodstream to prevent pregnancy. It is more than 99 percent effective.
 "This drug presents another long-term, effective option for women to prevent pregnancy," said FDA Commissioner David A. Kessler, M.D. "As an injectable, given once every three months, Depo Provera eliminates problems related to missing a daily dose."
 Depo Provera is available in 150 mg. single dose vials from doctors and clinics and must be given on a regular basis to maintain contraceptive protection. If a patient decides to become pregnant, she discontinues the injections.
 As with any such products, FDA advises patients to discuss the benefits and risks of Depo Provera with their doctor or other health care professional before making a decision to use it.
 Depo Provera's effectiveness as a contraceptive was established in extensive studies by the manufacturer, the World Health Organization and health agencies in other countries. U.S. clinical trials, begun in 1963, also found Depo Provera effective as an injectable contraceptive.
 The most common side effects are menstrual irregularities and weight gain. In addition, some patients may experience headache, nervousness, abdominal pain, dizziness, weakness or fatigue. The drug should not be used by women who have acute liver disease, unexplained vaginal bleeding, breast cancer or blood clots in the legs, lungs or eyes.
 The labeling advised doctors to rule out pregnancy before prescribing the drug, due to concerns about low birth weight in babies exposed to the drug. Recent data have also demonstrated that long-term use may contribute to osteoporosis. The manufacturer will conduct additional research to study this potential effect.
 Depo Provera was developed in the 1960s and has been approved for contraception in many other countries. The UpJohn Company of Kalamazoo, Mich., which will market the drug under the name, Depo Provera Contraceptive Injection, first submitted it for approval in the United States in the 1970s. At that time, animal studies raised questions about its potential to cause breast cancer. Worldwide studies have since found the overall risk of cancer, including breast cancer in humans, to be minimal, if any.
 FDA is one of the eight Public Health Service agencies within HHS.
 -0- 10/29/92
 /NOTE: Attention TV broadcasters: please use open caption for the hearing-impaired./
 /CONTACT: Susan Cruzan of the Food and Drug Administration, 301-443-3285 or, after hours, 301-926-7081/ CO: Food and Drug Administration; The UpJohn Company ST: District of Columbia IN: MTC SU: EXE


DC -- DC010 -- 6540 10/29/92 11:31 EST
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Date:Oct 29, 1992
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